drugset / Trial / NCT02736019

Tramadol Versus Celecoxib for Reducing Pain During Office Hysteroscopy in Post Menopausal Women

NCT02736019

Phase 3 Unknown 210 enrolled Cairo University
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Two hundreds and twenty five postmenopausal women undergoing outpatient hysteroscopy and endometrial biopsy will be randomly divided into three equal groups. To ensure blinding the investigators will use the double dummy technique in which group 1 will receive Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg (Celebrex® 200, Pfizer, USA) in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol and a placebo similar to Celecoxib. All drugs will be given 2 hours before the procedure. An independent person will generate the allocation sequence using computer generated random numbers. Patient's perception of pain will be assessed for each group during the procedure, immediately after and 30 min after the procedure with the use of visual analogue scale (VAS).

Timeline

Start
2016-06
Primary completion
2017-04
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Celecoxib Other / unclassified 200 mg Oral
Comparator Tramadol Other / unclassified 100 mg Oral

Indications

No indication recorded.